HealthyPhase 1NCT03886688
HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers
A Phase 1 study testing HEC53856 in people with Healthy, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HEC53856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2019to 1 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- age: 18-45 years old(18 and 45 included).
- B.W. male> 50kg, female> 45kg, BMI - 18-28 kg/m^2
- females must not be pregnant and males and females must agree to use contraception during the study.
- able to give informed consent and comply with protocol.
- physical examination and vital signs without clinically significant abnormalities.
- agree to use contraceptive methods after informed consent acquisition through 6 months after the last administration of the study drug.
Who cannot join
- history or presence of severe gastrointestinal or systemic disorders (e.g. respiratory, endocrine, immunological, dermatological, neurological, psychiatric, renal, hepatic disease etc.)
- history or presence of significant alcoholism or drug abuse within past 5 years
- smokers, who smoke more than 5 cigarettes per day within past 3 months
- heavy drinker, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- donated blood or massive blood loss within 3 months before screening (>450 mL）
- have any disease that increases the risk of bleeding or thrombus, such as acute gastritis or stomach and duodenal ulcers;
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- clinically significant laboratory findings during screening
- history or presence of clinically significant ECG abnormalities
- participated in drug research study within past 3 months
- used over-the-counter/ prescription/ herbal medications/ supplements within past 14 days.
- Strenuous activity (as assessed by the investigator) is prohibited from 2 weeks prior to admission until discharge from the unit.
- female in pregnancy or lactation.
- viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
- the investigator believes that the one should not be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Dose-escalation, Pharmacokinetic Study of Single and Multiple Oral Dosing of HEC53856, A Novel HIF-PHD Inhibitor, in Healthy Non-elderly Volunteers.
To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.
Read the detailed description
This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.
- Conditions
- Healthy
- Being tested
- HEC53856, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC53856Drug
Also called HEC53856 capsule
oral administration
placeboDrug
Also called HEC53856 matching placebo capsule
oral administration
| Study group | Role | What they receive |
|---|---|---|
| single ascending | Experimental | Drug or placebo, oral, fast, single dose ascending Receives: Drug: HEC53856; Drug: placebo |
| multiple ascending | Experimental | Drug or placebo, oral, fast, multiple dose ascending Receives: Drug: HEC53856; Drug: placebo |
| Food Effect | Experimental | Drug or placebo, oral, fed or fast, single dose Receives: Drug: HEC53856; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events [Safety and Tolerability]
To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule
Measured: Up to Day 10 after last dose
Secondary outcomes (4)
AUC0-t
Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
Measured: Up to 96 hours after dosing
Cmax
Maximum observed plasma concentration
Measured: Up to 96 hours after dosing
Tmax
Time of the maximum observed plasma concentration
Measured: Up to 96 hours after dosing
T T½
Apparent terminal elimination half-life
Measured: Up to 96 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start14 May 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ding Yanhua, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886688
- Sponsor's protocol ID
- HEC53856-P-01
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled, Dose-escalation, Pharmacokinetic Study of Single and Multiple Oral Dosing of HEC53856, A Novel HIF-PHD Inhibitor, in Healthy Non-elderly Volunteers.
- ClinicalTrials.gov ID
- NCT03886688
- Acronym / sponsor ID
- HEC53856-P-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.
Detailed description
This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single ascending | Experimental | Drug: HEC53856, Drug: placeboDrug or placebo, oral, fast, single dose ascending |
| multiple ascending | Experimental | Drug: HEC53856, Drug: placeboDrug or placebo, oral, fast, multiple dose ascending |
| Food Effect | Experimental | Drug: HEC53856, Drug: placeboDrug or placebo, oral, fed or fast, single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- healthy volunteers
- age: 18-45 years old(18 and 45 included).
- B.W. male> 50kg, female> 45kg, BMI - 18-28 kg/m^2
- females must not be pregnant and males and females must agree to use contraception during the study.
- able to give informed consent and comply with protocol.
Key exclusion criteria (14 listed)
- history or presence of severe gastrointestinal or systemic disorders (e.g. respiratory, endocrine, immunological, dermatological, neurological, psychiatric, renal, hepatic disease etc.)
- history or presence of significant alcoholism or drug abuse within past 5 years
- smokers, who smoke more than 5 cigarettes per day within past 3 months
- heavy drinker, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- donated blood or massive blood loss within 3 months before screening (>450 mL）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC53856Also: HEC53856 capsuleoral administration | Drug | Food Effect, multiple ascending, single ascending |
| placeboAlso: HEC53856 matching placebo capsuleoral administration | Drug | Food Effect, multiple ascending, single ascending |
Primary outcome
Incidence of Adverse Events [Safety and Tolerability]
Time frame: Up to Day 10 after last dose
To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule
4 secondary outcomes
AUC0-t
Time frame: Up to 96 hours after dosing
Cmax
Time frame: Up to 96 hours after dosing
Tmax
Time frame: Up to 96 hours after dosing
T T½
Time frame: Up to 96 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ding Yanhua, Doctor principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEC53856 in people with Healthy, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events [Safety and Tolerability] (time frame: Up to Day 10 after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.